Not having a business associate agreement (BAA) with email service providers increases the risk of HIPAA violations due to insufficient safeguards for protected health information (PHI). This negligence can lead to potential fines from the Department of Health and Human Services (HHS), reputational damage, legal liabilities, patient lawsuits, and heightened vulnerability to data breaches. BAAs ensure email providers comply with HIPAA regulations, protect patient privacy, and maintain organizational integrity.
According to NCBI, "Protected health information breaches have impacted over 176 million patients in the United States from 2009 to 2020. Most of these breaches have occurred due to the carelessness of employees and failure to comply with HIPAA rules versus external hackers.". HIPAA establishes national standards for the protection of PHI, which includes any information about health status, provision of healthcare, or payment for healthcare that can be linked to an individual. Covered entities and business associates must adhere to these regulations to ensure patient privacy and data security.
A BAA ensures that an email service provider, as a business associate, handles PHI with the same level of care and security that HIPAA requires. It outlines specific purposes for accessing PHI, mandates security measures like encryption and access controls, and establishes procedures for reporting breaches promptly and effectively. Integrating BAAs into email service agreements allows healthcare organizations to protect patient information and maintain compliance with HIPAA regulations.
Read more: FAQs: Business associate agreements (BAAs)
Without a BAA, there is no legally binding agreement detailing the email provider's responsibilities for protecting PHI. That makes it challenging for the covered entity to demonstrate they have taken reasonable steps to ensure HIPAA compliance.
If a data breach involving PHI occurs due to inadequate safeguards by the email provider, the covered entity could face substantial fines. Advocate Health Care (AHC) faced a $5.55 million HIPAA fine in 2016 following two data breaches and a failure to attain a BAA and this was reported as one of the largest HIPAA violation cases.
Related: What are the penalties for breaching HIPAA?
A HIPAA breach can severely damage a covered entity's reputation, leading to patient distrust and potential loss of business. Patients expect their healthcare providers to protect their sensitive information, and a breach can erode this trust.
The patients affected by a PHI breach may have legal grounds to sue the covered entity. That can result in costly legal battles and settlements, further straining the organization's resources.
Without a BAA, email providers may not implement necessary security measures like encryption and access controls, increasing the risk of data breaches. Email is the second most common breach location, affecting 108,199 individuals. The combination of human error, inadequate encryption, and the systematic use of email in healthcare settings contributes to its frequent occurrence.
Healthcare organizations should choose email service providers that offer HIPAA compliant solutions and are willing to sign a BAA. Regular security audits can help ensure ongoing compliance.
Related: Features to look for in a HIPAA compliant email service provider
Ensure that all relevant service providers sign a BAA. Key clauses should cover permissible uses of PHI, security safeguards, and breach notification procedures. Regularly review and update BAAs to reflect any changes in services or regulations.
Train employees on secure email practices and the importance of HIPAA compliance. Regular training sessions can help maintain a high level of awareness and adherence to privacy and security protocols.
Patient consent ensures transparency and compliance with HIPAA regulations regarding the secure transmission of sensitive health information, reinforcing patient trust.
Ensure the provider offers robust encryption and secure storage options, and signs a BAA to guarantee adherence to HIPAA standards for protecting PHI.
One common mistake is assuming standard email services automatically comply with HIPAA without signing a BAA, which could lead to compliance gaps and potential breaches.